The FDA approved Ogsiveo (nirogacestat), the first drug indicated for locally aggressive, noncancerous tumors, on Nov. 27.
Desmoid tumors are a rare subtype of soft tissue sarcomas that can cause pain, limited mobility and a decreased quality of life, the FDA said. Surgical removal has historically been used to treat these noncancerous tumors, but there is a high risk of it returning.
In a clinical trial of 142 adult patients, study participants received either 150 milligrams of Ogsiveo or a placebo twice a day. Progression-free survival was found in 41% of those taking Ogsiveo and 8% in the placebo group.
The FDA awarded the approval to SpringWorks Therapeutics.